- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02848781
Pan-Asia United States PrEvention of Sudden Cardiac Death Catheter Ablation Trial (PAUSE-SCD)
PAUSE-SCD: Pan-Asia United States PrEvention of Sudden Cardiac Death Catheter Ablation Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Subjects who meet inclusion/exclusion criteria will be entered into the randomized trial. Randomization will be 1:1 between control group and ablation group. Those randomized to the control group will receive ICD therapy and routine drug therapy (including antiarrhythmic drugs as indicated). Subjects randomized to the ablation group will receive ablation therapy plus ICD for ventricular tachycardia. Patients that refuse ICD therapy and undergo ablation only will be enrolled in a prospective registry.
Follow-up will be performed prior to hospital discharge for incision check and device interrogation as is standard of care. In addition, routine device and clinical follow-up will be scheduled at 1, 3, 6, 12, 18, and 24 months. Electrocardiography (ECG) will be performed pre-implant and prior to hospital discharge. Echocardiography (TTE) will be performed pre-implant and at 12 and 24 months.
Patients that refuse ICD implantation will not be randomized and will be approached for inclusion into a registry if they undergo catheter ablation without an ICD. Basic demographics and medical history will be collected from registry subjects upon enrollment. Registry subjects will receive follow-up for routine clinical care every 6 months to check on their overall status.
120 subjects will be randomized. An additional 60 subjects will enrolled into the registry.
As of the time protocol revision C changes were made (07Nov2016), 33 subjects have been randomized. There has not been any preliminary or interim analysis of any data at this point. The study-sponsor has not had any access to any clinical follow-up for the patients enrolled to date.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Beijing, China
- Fuwai Cardiovascular Hospital
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Chengdu, China
- HuaXi hospital
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Guangzhou, China
- Guangdong General Hospital
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Hangzhou, China
- Sir Run Run Shaw Hospital
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Nanjing, China
- Nanjing First Affiliated Hospital
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Shenyang, China
- PLA Shenyang General Hospital
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Saitama, Japan
- Dokkyo Medical University, Saitama Medical Center
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Tokyo, Japan
- Kyorin University Hospital
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Tsukuba, Japan
- Tsukuba University
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Seoul, Korea, Republic of
- Korea University
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Taipei, Taiwan
- Taipei Veterans General Hospital
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Arizona
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Phoenix, Arizona, United States, 85006
- Banner University Medical Center Phoenix
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patient is receiving a new implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy device (CRT-D) implant that has study required programing capabilities and is appropriate for remote monitoring. Patient who has received the ICD / CRT-D within 90 days of enrollment can also be enrolled.
Patient who has a high risk of ICD shock as shown by documented Monomorphic VT (MMVT) by one or more of the following:
- Spontaneous MMVT
- Inducible MMVT during electrophysiology study,
- Inducible MMVT during noninvasive programmed stimulation study *Inducible MMVT is defined as MMVT > 30 seconds or requiring electrical termination (ATP or cardioversion)
- Patient has ejection fraction < 50% or right ventricular dysfunction
- Patient has a cardiomyopathy with structural heart disease of any cause
Exclusion Criteria:
- Any history of debilitating stroke with neurologic deficit
- ST-segment elevation myocardial infarction or previous cardiac surgery within 60 days prior to enrollment
- Patient is pregnant or nursing
- Patient has chronic New York Heart Association (NYHA) class IV heart failure
- Patient has incessant VT necessitating immediate treatment
- Patient has ventricular tachycardia/ventricular fibrillation thought to be from channelopathies
- Limited life expectancy (less than one year)
- Patient has current class IV angina
- Recent coronary artery bypass graft or percutaneous coronary intervention (< 45 days)
- Patient is currently participating in another investigational drug or device study
- Known presence of intracardiac thrombi
- Prosthetic mitral or aortic valve or mitral or aortic valvular heart disease requiring immediate surgical intervention
- Major contraindication to anticoagulation therapy or coagulation disorder
- Left Ventricular Ejection Fraction < 15%
- Patient has had a previous ablation procedure for VT, excluding remote (> 3 months) outflow tract tachycardia
- Patient has glomerular filtration rate (GFR) < 30 mL/min/1.73m2
- Patient has peripheral vascular disease that precludes left ventricular access
- Patient is thought to have idiopathic outflow VT as only VT
- Patient has a premature ventricular contraction (PVC) or VT induced cardiomyopathy that is expected to resolve with ablation and will not require an ICD
- Patient has reversible cause of VT
- Patient does not meet criteria for ICD or CRT-D
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: ICD with Ablation
Patient will receive an implantable cardioverter defibrillator (ICD) with catheter ablation and standard medical management.
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An ICD is a battery-powered device placed under the skin that keeps track of heart rate.
Thin wires connect the ICD to the heart.
If an abnormal heart rhythm is detected, the device will deliver an electric shock to restore a normal heartbeat.
Catheter ablation is a procedure that uses radiofrequency energy to destroy a small area of heart tissue that is causing rapid and irregular heartbeats.
Destroying this tissue helps restore the heart's regular rhythm.
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Active Comparator: ICD Only
Patient will receive an implantable cardioverter defibrillator (ICD) and standard medical management.
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An ICD is a battery-powered device placed under the skin that keeps track of heart rate.
Thin wires connect the ICD to the heart.
If an abnormal heart rhythm is detected, the device will deliver an electric shock to restore a normal heartbeat.
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Active Comparator: Ablation Only (Registry)
The registry will enroll patients who refuse an implantable cardioverter defibrillator (ICD) and are thus not randomized.
This arm will assess the efficacy of catheter ablation in the absence of background ICD therapy.
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Catheter ablation is a procedure that uses radiofrequency energy to destroy a small area of heart tissue that is causing rapid and irregular heartbeats.
Destroying this tissue helps restore the heart's regular rhythm.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Freedom From Recurrent VT, Cardiovascular Rehospitalization, and All-cause Mortality
Time Frame: 2 years
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The primary endpoint is a composite.
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2 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Freedom From Recurrent VT
Time Frame: 2 years
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Recurrent VT is defined as any appropriate ICD therapy (shock or ATP) or documented sustained monomorphic VT >30 seconds.
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2 years
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Freedom From Cardiovascular Rehospitalization
Time Frame: 2 years
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Cardiovascular rehospitalization is defined as a hospital admission after the randomized procedure for heart failure, procedure-associated complication, or arrhythmia-related causes during the follow-up period.
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2 years
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Freedom From All-cause Mortality
Time Frame: 2 years
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2 years
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Other Outcome Measures
Outcome Measure |
Time Frame |
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Comparison of Outcomes in Ablation Only Registry With Randomized Patients
Time Frame: 2 years
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2 years
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Roderick Tung, MD, University of Chicago
Publications and helpful links
General Publications
- Kheiri B, Barbarawi M, Zayed Y, Hicks M, Osman M, Rashdan L, Kyi HH, Bachuwa G, Hassan M, Stecker EC, Nazer B, Bhatt DL. Antiarrhythmic Drugs or Catheter Ablation in the Management of Ventricular Tachyarrhythmias in Patients With Implantable Cardioverter-Defibrillators: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Circ Arrhythm Electrophysiol. 2019 Nov;12(11):e007600. doi: 10.1161/CIRCEP.119.007600. Epub 2019 Nov 8.
- Tung R, Xue Y, Chen M, Jiang C, Shatz DY, Besser SA, Hu H, Chung FP, Nakahara S, Kim YH, Satomi K, Shen L, Liang E, Liao H, Gu K, Jiang R, Jiang J, Hori Y, Choi JI, Ueda A, Komatsu Y, Kazawa S, Soejima K, Chen SA, Nogami A, Yao Y; PAUSE-SCD Investigators. First-Line Catheter Ablation of Monomorphic Ventricular Tachycardia in Cardiomyopathy Concurrent With Defibrillator Implantation: The PAUSE-SCD Randomized Trial. Circulation. 2022 Jun 21;145(25):1839-1849. doi: 10.1161/CIRCULATIONAHA.122.060039. Epub 2022 May 4.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00000272
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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